Devices and methods for verifying a sample volume

ABSTRACT

A system for verifying a sample volume includes a sample reservoir and a volumetric verification device. The sample reservoir defines an inner volume and is configured to receive a volume of bodily fluid. The inner volume of the sample reservoir contains an additive. The volumetric verification device includes a first indicator and a second indicator. The volumetric verification device is configured to selectively engage the sample reservoir to (1) place the first indicator in a first position along a length of the sample reservoir such that the first indicator is substantially aligned with a surface and/or meniscus of the additive and (2) place the second indicator in a second position along the length of the sample reservoir such that the second indicator is substantially aligned with a predetermined fill volume when bodily fluid is transferred to the inner volume.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/157,145 entitled, “Devices and Methodsfor Verifying a Sample Volume,” filed May 5, 2015, the disclosure ofwhich is incorporated herein by reference in its entirety.

BACKGROUND

Embodiments described herein relate generally to the parenteralprocurement of bodily fluid samples, and more particularly to devicesand methods for parenterally procuring bodily fluid samples with reducedcontamination from microbes and for verifying the bodily fluid samplevolumes.

The in vitro diagnostics industry has expanded the types of approachesemployed to identify, categorize, type, determine sensitivity andsusceptibility (e.g., to specific antibiotics), and/or to otherwisediscern desired information about bodily fluid samples with increasedspeed, specificity, and accuracy. For example, some such approachesinclude DNA/RNA sequencing, biological marker identification, massspectrometry, centrifuging, magnetic separation, microfluidic isolation,molecular analysis, polymerase chain reaction (PCR) analysis, wholeblood analysis, and/or the like. In some instances, such approaches canbe used, for example, in microbial testing of parenterally obtainedbodily fluids to determine the presence of one or more potentiallyundesirable microbes, such as bacteria, fungi, or yeast (e.g., Candida).

In some instances, microbial testing may include diagnostic methodsincluding but not limited to incubating patient samples in one or moresterile vessels containing culture media that is conducive to microbialgrowth, molecular sample analysis, gene sequencing, PCR-basedapproaches, mass spectrometry, and/or the like, as noted above.Generally, when such microbes are present in the patient sample, themicrobes flourish over time in the culture medium or can be detectedand/or identified by one of the aforementioned technological approaches.When culture medium is utilized for microbial testing, after a variableamount of time (e.g., a few hours to several days), organism growth canbe detected by automated, continuous monitoring (e.g., by detectingcarbon dioxide and/or the like). The culture medium can then be testedfor the presence of the microbes, which if present, suggests thepresence of the same microbes in the patient sample and thus, in thebodily fluid of the patient from which the sample was obtained. Whenother technologies are used for microbial testing, the amount of timerequired to determine a presence of microbes may vary (e.g. from nearlyinstantaneously to several minutes, hours, or days). These technologies,however, are still sensitive to the inherent quality and/or integrity ofthe specimen that is being analyzed. Accordingly, when microbes aredetermined to be present in the culture medium or identified by anotherdiagnostic test, the patient may be prescribed one or more antibioticsor other treatments specifically designed to treat or otherwise removethe undesired microbes from the patient.

Patient samples, however, can become contaminated during procurementand/or otherwise can be susceptible to false positive results. Forexample, microbes from a bodily surface (e.g., dermally-residingmicrobes) that are dislodged during needle insertion into a patient,either directly or indirectly via tissue fragments, hair follicles,sweat glands, and other skin adnexal structures, can be subsequentlytransferred to a culture medium with the patient sample and/or includedin the specimen that is to be analyzed for non-culture based testing.Another possible source of contamination is from the person drawing thepatient sample. For example, a doctor, phlebotomist, nurse, etc. cantransfer contaminants from their body (e.g., finger, arms, etc.) to thepatient sample and/or to the equipment containing the patient sample.Specifically, equipment and/or devices used during a patient sampleprocurement process (e.g., patient to needle, needle/tubing to samplevessels, etc.) often include multiple fluidic interfaces that can eachintroduce points of potential contamination. In some instances, suchcontaminants may thrive in a culture medium and/or may be identified byanother diagnostic technology and eventually yield a positive microbialtest result, thereby falsely indicating the presence of such microbes invivo.

In some instances, false positive results and/or false negative resultscan be attributed to a specific volume of the patient sample. Forexample, some in vitro diagnostic (IVD) tests are sensitive to the ratiobetween bodily fluid collected in the sample reservoir and thepreexisting contents in the sample reservoir which could include culturemedium, additives (such as those described herein), and/or the like thatare placed into the sample reservoir during manufacturing. In theseinstances, accurate results of the IVD test may depend on an appropriateamount of bodily fluid collected in the sample reservoir. For example,overfilling of volume-sensitive blood culture bottles can lead to falsepositive results as noted in the instructions for use and/or warninglabeling from manufacturers of such culture bottles, as well asassociated automated continuous monitoring microbial detection systems.On the other hand, insufficient patient sample volume within a culturemedium can result in false negative results. By way of example, in astudy performed by the Mayo Clinic entitled, Optimized PathogenDetection with 30- Compared to 20-Milliliter Blood Culture Draws,Journal of Clinical Microbiology, December 2011, a patient sample volumeof 20 milliliters (mL) can result in detection of about 80% ofbacteremias present in a patient sample, a patient sample volume of 40mL can result in detection of about 88% of the bacteremias, and apatient sample volume of 60 mL can result in detection of about 99% ofthe bacteremias. In some instances, such as in patients with sepsis, aconcentration of colony forming units (CFUs) in the septic patient'sbloodstream can be highly variable (including very low levels of lessthan 1 CFU per 10 ml of blood). Thus, ensuring that a sufficient amountof blood is collected and analyzed is desired for clinical confidence inthe accuracy of the microbial test result.

While placing blood in a culture medium is a ‘standard of care’ today, anumber of new technologies (examples of which are noted above) holdpromise in increasing the pace with which microbes (and antibioticsusceptibility and/or sensitivity) can be identified in a bodily fluidsample. However, procuring a sufficient volume of blood that is analyzedremains desirable as a small volume of blood may not contain a CFU orother critical identifiable cell, biomaterial, compound, marker,organism, or the like that is actually present in the patient'sbloodstream, thereby falsely indicating that a patient is not septic.

Such inaccurate results because of contamination, insufficient patientsample volume, and/or the like are a concern when attempting to diagnoseor treat a suspected illness or condition. For example, false negativeresults from microbial tests may result in a misdiagnosis and/or delayedtreatment of a patient illness, which, in some cases, could result inthe death of the patient. Conversely, false positive results frommicrobial tests may result in the patient being unnecessarily subjectedto one or more anti-microbial therapies, which may cause serious sideeffects to the patient including, for example, death, as well as producean unnecessary burden and expense to the health care system due toextended length of patient stay and/or other complications associatedwith erroneous treatments. Additionally, the use of diagnostic imagingequipment attributable to these false positive results is also a concernfrom both a cost as well as patient safety perspective given theadditional diagnostic procedures that are performed, potential foradditional false positive or false negative results, as well as concernsaround unnecessary exposure to concentrated radiation associated with avariety of imaging procedures (e.g., CT scans) has many known adverseimpacts on long-term patient health.

As such, a need exists for sterile bodily fluid collection devices andmethods that reduce microbial contamination in bodily fluid testsamples. Additionally, a need exists for such bodily fluid collectiondevices to include a means for accurately verifying, measuring, and/orotherwise assessing and confirming a volume of bodily fluid transferredfrom a patient to a sample reservoir or culture medium that can becommunicated via visual, tactile, or other means to a healthcarepractitioner procuring the patient sample in substantially real-time(e.g. at the patient bedside, in an outpatient clinic or the like).

SUMMARY

Devices for parenterally procuring bodily fluid samples with reducedcontamination from microbes and for volumetric verification of thebodily fluid samples are described herein. In some embodiments, anapparatus for obtaining a bodily fluid sample from a patient includes atransfer device, a sample reservoir, and a volumetric verificationdevice. The transfer device includes a distal end portion configured tobe placed in fluid communication with the patient and a proximal endportion configured to be placed in fluid communication with the samplereservoir. The volumetric verification device is disposed about aportion of the fluid reservoir such that an indicator of the volumetricverification device is associated with a predetermined or variablevolume of the bodily fluid sample. By ensuring that the appropriateamount (e.g., the predetermined amount) of bodily fluid is collectedinto a sample reservoir for sensitive testing (e.g., IVD tests),increased sensitivity, specificity, consistency, reliability, and/oraccuracy of results can be achieved, which in turn, increase clinicalconfidence that the results of such tests (e.g., IVD tests) arerepresentative of the patient's in vivo condition.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a bodily fluid collection deviceaccording to an embodiment.

FIGS. 2-4 are various views of a sample reservoir and a volumetricverification device according to an embodiment.

FIG. 5 is a front view of a sample reservoir and a volumetricverification device according to an embodiment.

FIG. 6 is a front view of a sample reservoir and a volumetricverification device according to an embodiment.

FIG. 7 is a side view of a cradle coupled to a first volumetricverification device and a second volumetric verification device, whichin turn are disposed about a portion of a first sample reservoir and asecond sample reservoir, respectively, according to an embodiment.

FIG. 8 is a perspective view of the cradle coupled to the firstvolumetric verification device and the second volumetric verificationdevice of FIG. 7.

FIG. 9 is a rear perspective view of the first volumetric verificationdevice and the second volumetric verification device of FIG. 7.

FIG. 10 is a front perspective view of the cradle of FIG. 7.

FIG. 11 is a flowchart illustrating a method of verifying a samplevolume according to an embodiment.

DETAILED DESCRIPTION

Devices for parenterally procuring bodily fluid samples with reducedcontamination from microbes and for volumetric verification of thebodily fluid samples are described herein. In some embodiments, a systemfor verifying a sample volume includes a sample reservoir and avolumetric verification device. The sample reservoir defines an innervolume and is configured to receive a volume of bodily fluid. The innervolume of the sample reservoir contains an additive. The volumetricverification device includes a first indicator and a second indicator orplurality thereof. The volumetric verification device is configured toselectively engage the sample reservoir to (1) place the first indicatorin a first position along a length of the sample reservoir such that thefirst indicator is substantially aligned with a surface of the additiveor other additive in the sample reservoir and (2) place the secondindicator in a second position along the length of the sample reservoirsuch that the second indicator is substantially aligned with apredetermined fill volume when bodily fluid is transferred to the innervolume.

In some embodiments, a system for verifying a sample volume includes asample reservoir and a volumetric verification device. The samplereservoir defines an inner volume and is configured to receive a volumeof bodily fluid. The inner volume contains an additive. The samplereservoir includes a label having a volumetric indicator portionconfigured to provide an indication of a fill volume within the samplereservoir. The volumetric verification device includes a marker. Thevolumetric verification device is configured to selectively engage thesample reservoir to place the marker in a predetermined position alongthe volumetric indicator portion of the sample reservoir. Thepredetermined position is based the additive contained in the innervolume.

A method for verifying a sample volume of bodily fluid withdrawn from apatient using a volumetric verification device includes coupling thevolumetric verification device to a sample reservoir such that anindicator of the volumetric verification device is in a predeterminedposition along a length of the sample reservoir. The sample reservoirdefines an inner volume containing an additive. The inner volume isconfigured to receive a predetermined volume of bodily fluid. Fluidcommunication is established between the patient and the samplereservoir. A volume of bodily fluid is transferred from the patient tothe sample reservoir. The method includes verifying the volume of bodilyfluid transferred to the sample reservoir is substantially thepredetermined volume.

In some embodiments, an apparatus for obtaining a bodily fluid samplefrom a patient includes a transfer device, a sample reservoir, and avolumetric verification device. The transfer device includes a distalend portion configured to be placed in fluid communication with thepatient and a proximal end portion configured to be placed in fluidcommunication with the sample reservoir. The volumetric verificationdevice is disposed about a portion of the fluid reservoir such that anindicator of the volumetric verification device is associated with apredetermined or variable volume of the bodily fluid sample.

As used in this specification and the appended claims, the singularforms “a,” “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, the term “a member” isintended to mean a single member or a combination of members, “amaterial” is intended to mean one or more materials, or a combinationthereof.

As used herein, “bodily fluid” can include any fluid obtained from abody of a patient, including, but not limited to, blood, cerebrospinalfluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleuralfluid, amniotic fluid, and the like, or any combination thereof.

As used herein, the terms “first, predetermined amount,” “first amount,”and “first volume” describe an amount of bodily fluid configured to bereceived or contained by a first reservoir or a pre-sample reservoir.That is to say, the first predetermined amount refers to a desired orgiven amount or volume of the bodily fluid within an accepted tolerance.While the terms “first amount” and “first volume” do not explicitlydescribe a predetermined amount, it should be understood that the firstamount and/or the first volume is the first, predetermined amount unlessexplicitly described differently.

As used herein, the terms “second amount” and “second volume” describean amount of bodily fluid configured to be received or contained by asecond reservoir or sample reservoir, typically after withdrawing thefirst predetermined volume of bodily fluid. The second amount can be anysuitable amount of bodily fluid and need not be predetermined.Conversely, when explicitly described as such, the second amountreceived and contained by the second reservoir or sample reservoir canbe a second, predetermined amount.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used herein, the terms “proximal” and “distal” refer to the directioncloser to and away from, respectively, a user who would place the deviceinto contact with a patient. Thus, for example, the end of a devicefirst touching the body of the patient would be the distal end, whilethe opposite end of the device (e.g., the end of the device manipulatedby the user) would be the proximal end of the device.

As used herein, the terms “about,” “approximately,” and “substantially”when used in connection with a numerical value convey that the value sodefined is nominally the value stated. Said another way, the termsabout, approximately, and substantially when used in connection with anumerical value generally include the value stated plus or minus a giventolerance. For example, in some instances, a suitable tolerance can beplus or minus 10% of the value stated; thus, about 0.5 would include anyvalue between 0.45 and 0.55, about 10 would include any value between 9to 11, about 1000 would include any value between 900 to 1100. In otherinstances, a suitable tolerance can be plus or minus an acceptablepercentage of the last significant figure in the value stated. Forexample, a suitable tolerance can be plus or minus 10% of the lastsignificant figure; thus, about 10.1 would include any value between10.09 and 10.11, approximately 25 would include any value between 24.5and 25.5. Such variance can result from manufacturing tolerances orother practical considerations (such as, for example, tolerancesassociated with a measuring instrument, acceptable human error, or thelike).

When describing a relationship between a predetermined volume of bodilyfluid and a collected volume of bodily fluid the values include asuitable tolerance such as those described above. For example, whenstating that a collected volume of bodily fluid is substantially equalto a predetermined volume of bodily fluid, the collected volume and thepredetermined volume are nominally equal within a suitable tolerance. Insome instances, the intended use of the collected volume of bodily fluiddetermines the tolerance thereof. For example, in some instances, anassay of a blood culture can be about 99% accurate when the collectedvolume of blood is within 1.0% to 5.0% of the manufacturer's (orevidence-based best practices) recommended volume. By way of an example,a manufacturer's recommended volume for an assay of a bodily fluid canbe 10 milliliters (mL) per sample collection bottle, with a total offour or six collection bottles used (i.e., an aggregate volume of 40 mlto 60 ml) plus or minus 5% for about 99% confidence. Thus, a collectedvolume of 10.5 mL would provide results with a confidence equal to orgreater than about 99% confidence, while a collected volume of 11 mLwould provide results with less than about 99% confidence. In otherinstances, a suitable tolerance can be 0.1%, 0.5%, 1.0%, 2.0%, 3.0%,4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, or any fraction of a percenttherebetween. In still other instances, a tolerance can be greater than10.0%. Thus, any of the embodiments described herein can include and/orcan be used in conjunction with any suitable flow-metering and/orvolumetric verification mechanism or device that is configured to metera fluid flow and/or otherwise measure a volume of bodily fluid within asuitable tolerance. Moreover, the flow-metering and/or volumetricverification mechanism or device can be arranged to minimize oreliminate tolerance stacking that can result from a combination ofinaccurate measurement, human error, and/or the like.

The embodiments described herein include sample reservoirs andvolumetric verification devices that can be used with any suitablebodily fluid transfer device. For example, in some instances, theembodiments described herein can be used with a transfer device forparenterally procuring bodily fluid samples with reduced contaminantssuch as, dermally residing microbes. In some embodiments, the samplereservoirs and the volumetric verification devices described herein canbe used with a transfer device that is configured to divert a first,predetermined volume of bodily fluid to a pre-sample reservoir via afirst flow path, and subsequently, to transfer a predetermined volume ofthe bodily fluid to any of the fluid reservoirs described herein, via asecond flow path.

By way of example, FIG. 1 is a schematic illustration of a portion of abodily fluid transfer system 100, according to an embodiment. Generally,the bodily fluid transfer system 100 (also referred to herein as “fluidtransfer system” or “transfer system”) is used to withdrawal bodilyfluid from a patient such that a first portion or amount of thewithdrawn fluid is diverted away from a second portion or amount of thewithdrawn fluid that is to be used as a biological sample, such as fortesting for the purpose of medical diagnosis and/or treatment. In otherwords, the transfer system 100 can transfer a first, predeterminedamount of a bodily fluid to a first collection reservoir and cantransfer a second amount of bodily fluid to one or more bodily fluidcollection reservoirs fluidically isolated from the first collectionreservoir. Moreover, the transfer system 100 can meter the second amountof bodily fluid such that a volume associated therewith is substantiallya predetermined volume, as described in further detail herein.

As shown in FIG. 1, the transfer system 100 includes a transfer device110 that is in fluid communication with a pre-sample reservoir 118 and asample reservoir 120. The transfer device 110 can be any suitabletransfer device. For example, in some embodiments, the transfer device110 can be substantially similar to or the same as the devices includedin U.S. Pat. No. 8,535,241 entitled, “Fluid Diversion Mechanism forBodily-Fluid Sampling,” filed Oct. 12, 2012 (“the '241 patent”) and U.S.Pat. No. 9,060,724 entitled, “Fluid Diversion Mechanism for Bodily-FluidSampling,” filed May 29, 2013 (“the '724 patent”) the disclosures ofwhich are incorporated herein by reference in their entireties. In someembodiments, the transfer device 110 can include a device for metering avolumetric flow rate and/or otherwise can be substantially similar to orthe same as the devices included in U.S. Patent Publication No.2014/0155782 entitled, “Sterile Bodily-Fluid Collection Device andMethods,” filed Dec. 4, 2013 (“the '782 Publication”), the disclosure ofwhich is incorporated herein by reference in its entirety.

In the embodiment shown in FIG. 1, the transfer device 110 can include adiverter 111, a pre-sample reservoir 118, a sample reservoir 120,different from the pre-sample reservoir 118, and a flow controller 115.The diverter 111 includes an inlet port 112, a first outlet port 113,and a second outlet port 114. The inlet port 112 is coupled to and/orincludes a medical device defining a pathway for withdrawing and/orconveying the bodily fluid from the patient to the transfer device 100such as, for example, a needle, catheter, or other lumen-containingdevice (e.g., flexible, sterile tubing). In this manner, the diverter111 can receive the bodily fluid from the patient via the needle,catheter, or other lumen-containing device.

The first outlet port 113 of the diverter 111 is fluidically coupled tothe pre-sample reservoir 118. In some embodiments, the pre-samplereservoir 118 is monolithically formed with the first outlet port 113and/or a portion of the diverter 111. In other embodiments, thepre-sample reservoir 118 can be mechanically and fluidically coupled tothe diverter 111 via an adhesive, a resistance fit, a snap fit, amechanical fastener, any number of mating recesses, a threaded coupling,and/or any other suitable coupling or combination thereof. Similarlystated, the pre-sample reservoir 118 can be physically (e.g.,mechanically) coupled to the diverter 111 such that an interior volumedefined by the pre-sample reservoir 118 is in fluid communication withthe first outlet port 113 of the diverter 111. In still otherembodiments, the pre-sample reservoir 118 can be operably coupled to thefirst outlet port 113 of the diverter 111 via an intervening structure(not shown in FIG. 1), such as a flexible, sterile tubing. Moreparticularly, the intervening structure can define a lumen configured toplace the pre-sample reservoir 118 in fluid communication with the firstoutlet port 113.

The second outlet port 114 of the diverter 111 is configured tofluidically couple to the sample reservoir 120. In some embodiments, thesample reservoir 120 is monolithically formed with the second outletport 114 and/or a portion of the diverter 111. In other embodiments, thesample reservoir 120 can be mechanically coupled to the second outletport 114 of the diverter 111 or operably coupled to the second outletport 114 via an intervening structure (not shown in FIG. 1), such asdescribed above with reference to the pre-sample reservoir 118. Thesample reservoir 120 is configured to receive and contain the secondamount of the bodily fluid. For example, the second amount of bodilyfluid can be an amount withdrawn from the patient subsequent to thewithdrawal of the first amount, which is fluidically isolated within thepre-sample reservoir 118.

The flow controller 115 of the transfer device 110 can be any suitabledevice, member, mechanism, assembly, etc. For example, the flowcontroller 115 can be a flow control member defining a first flow pathand a second flow path, which is included in and/or otherwise disposedwithin a portion of the diverter 111 and movable between a firstconfiguration to a second configuration. In some embodiments, the flowcontroller 115, when in the first configuration, fluidically couples theinlet port 112 to the first outlet port 113 via the first flow path.Similarly, the flow controller 115, when in the second configuration,fluidically couples the inlet port 112 to the second outlet port 114 viathe second flow path. Accordingly, when the flow controller 115 is inthe first configuration, the second outlet port 114 is fluidicallyisolated from the inlet port 112, and when the flow controller 115 is inthe second configuration, the first outlet port 113 is fluidicallyisolated from the inlet port 112. In this manner, the flow controller115 can direct, or divert the first amount of the bodily fluid to thepre-sample reservoir 118 via the first outlet port 113 when the flowcontroller 115 is in the first configuration and can direct, or divertthe second amount of the bodily fluid to the sample reservoir 120 viathe second outlet port 114 when the flow controller 115 is in the secondconfiguration, as described in further detail herein. Although not shownin FIG. 1, in some embodiments, an actuator can be operably coupled tothe flow controller 115 and configured to move the flow controller 115between the first configuration and the second configuration, asdescribed in the '724 patent.

The pre-sample reservoir 118 of the transfer system 100 receives andcontains the first, predetermined amount of the bodily fluid. Moreparticularly, the pre-sample reservoir 118 fluidically isolates thefirst amount of bodily fluid contained therein from a second amount ofthe bodily fluid (different from the first amount of bodily fluid)subsequently withdrawn from the patient. The pre-sample reservoir 118can be any suitable reservoir for containing a bodily fluid, such as,for example, any of those described in detail in U.S. Pat. No. 8,197,420entitled, “Systems and Methods for Parenterally Procuring Bodily-FluidSamples with Reduced Contamination,” filed Dec. 13, 2007 (“the '420patent”), the disclosure of which is incorporated herein by reference inits entirety. As used in this specification, the terms “first,predetermined amount” and “first amount” describe an amount of bodilyfluid received or contained by the pre-sample reservoir 118.Furthermore, while the term “first amount” does not explicitly describea predetermined amount, the first amount is substantially the first,predetermined amount unless explicitly described differently.

The sample reservoir 120 can be any suitable reservoir(s) for containinga bodily fluid, including, for example, single use disposable collectiontubes, vacuum based collection tubes, a sample reservoir as described inthe '420 patent incorporated by reference above, and/or the like. Insome embodiments, the sample reservoir 120 can be substantially similarto or the same as known sample containers such as, for example, aVacutainer® (manufactured by BD), a BacT/ALERT® SN or BacT/ALERT® FA(manufactured by Biomerieux, Inc.), a Nanotainer™ (manufactured byTheranos), and/or any suitable reservoir, vial, microvial, microlitervial, container, microcontainer, and/or the like. In such embodiments,the sample reservoir 120 can include a vacuum seal that maintainsnegative pressure conditions (vacuum conditions) inside the samplereservoir 120, which in turn, can facilitate withdrawal of bodily fluidfrom the patient, through the diverter 111, and into the samplereservoir 120, via a vacuum or suction force, as described in furtherdetail herein. In some embodiments, the sample reservoir 120 can be anysuitable sample or culture bottle such as, for example, an aerobicculture bottle or an anaerobic culture bottle and the transfer system100 can be used to collect multiple aerobic and/or multiple anaerobicblood culture samples from a single venipuncture or single connection toan intravenous, central line and/or similar type of indwelling catheter.In this manner, the culture bottle can receive a bodily fluid sample,which can then be tested (e.g., via in vitro diagnostic (IVD) tests,and/or any other suitable test) for the presence of, for example,Gram-Positive bacteria, Gram-Negative bacteria, yeast, and/or any otherorganism and subsequently tested using, for example, a polymerase chainreaction (PCR)-based system to identify a specific organism. In someinstances, the culture bottle can receive a bodily fluid sample and theculture medium (disposed therein) can be tested for the presence of anysuitable organism. If such a test of the culture medium yields apositive result, the culture medium can be subsequently tested using aPCR-based system to identify a specific organism.

As used herein, the term “second amount” describes an amount of bodilyfluid received or contained by the sample reservoir 120. In someembodiments, the second amount can be any suitable amount of bodilyfluid and need not be predetermined. In other embodiments, the secondamount received and contained by the sample reservoir 120 is a second,predetermined amount. Moreover, in some embodiments, the second,predetermined amount can be associated with a desired volume of bodilyfluid plus or minus a tolerance for use in any suitable testing methodor the like. That is to say, in some instances, the second amount ofbodily fluid transferred into the sample reservoir 120 can have a volumethat is substantially equal to a desired volume for any given testingprocedure such as, for example, microbial testing and/or the like. Insome embodiments, the sample reservoir 120 can be transparent such thatthe user can have visual feedback to confirm bodily fluid flow into thesample reservoir 120. In some embodiments, the second amount of bodilyfluid can be any suitable volume of bodily fluid from, for example, oneor a few drops of bodily fluid (e.g., nanoliters or microliters) to 10milliliters (mL), 20 ml, 30 mL, 40 mL, 50 mL, 100 mL, 1,000 mL, 10,000mL, or more (or any value or fraction of a value therebetween) of bodilyfluid.

In some embodiments, the sample reservoir 120 can include, for example,any suitable additive, culture medium, substances, and/or the like. Forexample, in some embodiments, the sample reservoir 120 can include anaerobic or anaerobic culture medium (e.g., a growth medium or the like),which occupies at least a portion of the inner volume defined by thesample reservoir 120. In some embodiments, the sample reservoir 120 caninclude, for example, any suitable additive or the like such as,heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate,and/or the like, which similarly occupies at least a portion of theinner volume defined by the sample reservoir 120. In some instances, thesize, density, volume, and/or the like of the additive and/or culturemedium that are commonly found in sample reservoirs can vary based on,for example, tolerances, constituent substances comprising the additive,and/or the type of testing to be performed. Thus, the additive and/orthe culture medium disposed in the inner volume and a volume of bodilyfluid transferred into the sample reservoir collectively define a totalvolume and/or a total fill volume within the sample reservoir 120. Inother words, in some instances, determining a volume of bodily fluidtransferred into a sample reservoir may include accounting for a portionof a total volume attributable to a culture medium and/or additive.

While the term “culture medium” can be used to describe a substanceconfigured to react with organisms in a bodily fluid (e.g.,microorganisms such as bacteria) and the term “additive” can be used todescribe a substance configured to react with portions of the bodilyfluid (e.g., constituent cells of blood, serum, synovial fluid, etc.),it should be understood that a sample reservoir can include any suitablesubstance, liquid, solid, powder, lyophilized compound, gas, etc.Moreover, when referring to an “additive” within a sample reservoir, itshould be understood that the additive could be a culture medium, suchas an aerobic culture medium and/or an anaerobic culture mediumcontained in a culture bottle, an additive and/or any other suitablesubstance or combination of substances contained in a culture bottleand/or any other suitable reservoir such as those described above. Thatis to say, the embodiments described herein can be used with anysuitable fluid reservoir or the like containing any suitable substanceto accurately determine a volume of bodily fluid transferred into thefluid reservoir.

As shown in FIG. 1, the volumetric verification device 130 is configuredto engage (e.g., couple to, be disposed about, align with, and/or thelike) the sample reservoir 120 to provide an indication to a userassociated with a volume of bodily fluid disposed within the samplereservoir 120. As used herein, the volumetric verification device 130refers to a device used to indicate an existing volume of bodily fluid.That is to say, the volumetric verification device 130 is used toindicate a bulk volume or the like. The volumetric verification device130 (also referred to herein as “verification device”) can be anysuitable device, member, mechanism, assembly, etc. configured to providea user with an indicator associated with a volume of the bodily fluiddisposed within the sample reservoir 120. For example, in someembodiments, the verification device 130 can be disposed about a portionof the sample reservoir 120 and can include an indicator 148 or the likeconfigured to provide a visual indication of a volume of bodily fluidwithin the sample reservoir 120. In some embodiments, the indicator 148of the verification device 130 can provide a visual indication of avolume of the bodily fluid within the sample reservoir 120 relative toand/or at least partially associated with, the culture medium or otheradditive(s) disposed therein, as described in further detail withreference to specific embodiments.

In some embodiments, the transfer system 100 can optionally include oneor more flow-metering devices that can meter a flow of bodily fluidthrough the collection device. For example, a flow-metering device canbe in fluid communication with the first fluid flow path and/or thesecond fluid flow path to meter a flow of bodily fluid through thediverter 111 of the transfer device 110. In other embodiments, aflow-metering device can be in fluid communication with and/or otherwisedisposed in the first port 113 and/or the second port 114. In stillother embodiments, the flow-metering device can be in fluidcommunication with an inlet port or the like of the sample reservoir120. Moreover, the flow-metering device can include an indicator or thelike (e.g., a dial, a display, color, a haptic output device, anelectrical signal output device such as a wireless radio signal,Bluetooth radio signal, etc.) that can be configured to provide anindication to a user that is associated with a predetermined volumebeing transferred to the pre-sample reservoir 118 and/or the samplereservoir 120. In some embodiments, the flow-metering device can beoperably coupled to, for example, an actuator or the like, which canmove the flow controller 115 between its first configuration and itssecond configuration based on a desired volume of bodily fluid havingpassed through the flow-metering device. Thus, the flow-metering devicecan be used to ensure a desired volume of bodily fluid is transferred tothe pre-sample reservoir 118 and/or the sample reservoir 120 and can beused in conjunction with, for example, the verification device 130. Forexample, in some embodiments, the sample reservoir 120 and theverification device 130 can be used with and/or fluidically coupled to,the transfer device and/or collection devices described in detail in the'782 Publication.

FIGS. 2-10 illustrate various embodiments of sample reservoirs andvolumetric verification devices that can be used, for example, in thetransfer system 100 described above. In some instances, the embodimentsof the sample reservoirs described herein can be placed in fluidcommunication with, for example, bodily fluid transfer devices and/orbodily fluid collection devices such as those described in the '724patent and/or the '782 Publication. By way of example, FIGS. 2-4illustrate a sample reservoir 220 and a volumetric verification device230, according to an embodiment. Although not shown in FIGS. 2-4, thesample reservoir 220 and the volumetric verification device 230 can beused with any suitable bodily fluid transfer device and/or bodily fluidcollection device such as the transfer device 110 and/or the devicesdescribed in the '724 patent and/or the '782 Publication. That is tosay, the sample reservoir 220 can receive, from a transfer device, aflow of bodily fluid (e.g., blood) with reduced contaminants such as,for example, dermally residing microbes and/or the like, as described infurther detail herein.

As shown in FIGS. 2 and 3, the sample reservoir 220 includes a proximalend portion 221 and a distal end portion 223 and defines an inner volume(not shown). The proximal end portion 221 includes a port 222 configuredto receive an adapter, a puncture member, a coupler, a locking memberand/or the like. In some embodiments, the port 222 can be, for example,a self-healing port or the like. In some embodiments, the port 222 canbe a vacuum seal configured to maintain a vacuum condition within theinner volume until the port 222 is coupled to and/or punctured by anoutlet portion or adapter of a transfer device.

The sample reservoir 220 can be any suitable reservoir for containing abodily fluid, including, for example, single use disposable collectionreservoir, vacuum based collection reservoir (e.g., maintaining negativepressure conditions that can produce a suction or vacuum force), asample reservoir as described in the '420 patent incorporated byreference above, and/or the like. Moreover, while shown in FIGS. 2 and 3as having a bottle shape or the like, the sample reservoir can be anysuitable bottle, tube, vial, microvial, container, syringe, etc. Asdescribed above, in some embodiments, the reservoir 220 can be anaerobic culture bottle or an anaerobic culture bottles. That is to say,the sample reservoir 220 can include an aerobic or anaerobic culturemedium disposed within an inner volume defined by the sample reservoir220. Moreover, the culture medium disposed therein can be associatedwith one or more tests, procedures, and/or actions configured to, forexample, detect the presence of certain microbes that are known tothrive in that medium. In other embodiments, the sample reservoir 220can include common additives such as heparin, citrate, EDTA, oxalateand/or the like that are used to preserve specific characteristicsand/or qualities of a bodily fluid sample (e.g., blood) prior todiagnostic analysis.

Similarly, in some embodiments, the sample reservoir 220 is configuredto receive a predetermined volume of bodily fluid, which can beassociated with a test or the like to be performed thereon. For example,as shown in FIG. 3, the sample reservoir 220 includes a label 225, tag,or indicia disposed about the outside of the sample reservoir 220. Thelabel 225 includes, for example, a code portion 226 and a volumetricindicator portion 227. The code portion 226 can be, for example, a barcode, a quick response (QR) code, a radio-frequency identification(RFID) tag, a near field communication (NFC) tag, and/or the like. Insome embodiments, the code portion 226 can include a serial number. Inthis manner, the code portion 226 can provide a user (e.g., a doctor,phlebotomist, nurse, technician, etc.) with information associated withthe sample reservoir 220 such as, for example, the type of culturemedium disposed therein, the amount (e.g., volume, mass, density, etc.)of the culture medium disposed therein, a volume of bodily fluid thatthe sample reservoir 220 should receive, a tolerance value, the type oftests to be performed on the bodily fluid sample disposed therein,and/or the like. Thus, the user can determine, inter alia, the amount orthe volume of bodily fluid that he or she should transfer into thesample reservoir 220.

The volumetric indicator portion 227 can provide a visual indicatorassociated with the bodily fluid disposed in the sample reservoir 220.For example, the volumetric indicator portion 227 can include a set ofevenly spaced lines, tic marks, dashes, arrows, markers, and/or anyother suitable gradation or indicia that can be associated with aspecific volume of the sample reservoir 220 if filled to that point. Insome embodiments, the sample reservoir 220 can be substantiallytransparent, thereby allowing the user to visualize the sample disposedtherein. Thus, the user can assess the volume of the bodily fluiddisposed in the sample reservoir 220 by determining at what point alongthe indicator portion 227 that surface and/or meniscus of the bodilyfluid aligns. In some instances, however, the culture medium disposedwithin the sample reservoir can affect the representation of the volumeof bodily fluid disposed therein. For example, an amount of culturemedium disposed in the sample reservoir 220 can vary based on the typeof medium, the type of test with which the medium is associated,tolerances associated with the amount of the medium, and/or the like.Thus, as shown in FIG. 2, the volumetric verification device 230 can beconfigured to engage the sample reservoir 220 to meter, measure, and/orotherwise indicate to a user, the volume of the bodily fluid disposed inthe sample reservoir 220.

The volumetric verification device 230 (also referred to herein as“verification device”) can be any suitable device, member, mechanism,assembly, etc. configured to provide a user with an indicator associatedwith a volume of the bodily fluid disposed within the sample reservoir220. In some embodiments, the verification device 230 can have a sizeand/or shape that substantially corresponds to the sample reservoir 220.For example, the verification device 230 can be a substantially annularring or the like that defines an inner volume 236 configured to receivea portion of the sample reservoir 220. In other embodiments, theverification device 230 can be any suitable shape such as, for example,polygonal, oblong, and/or the like. In this manner, the verificationdevice 230 can be disposed about a portion of the sample reservoir 220such that a portion of the sample reservoir 220 is disposed in the innervolume 233, as shown in FIG. 2. More specifically, the verificationdevice 230 can have a shape that substantially corresponds to a shape ofthe sample reservoir 220 such that when the verification device 230 isdisposed about the sample reservoir 220, the verification device 230 issubstantially in a predetermined position relative to the samplereservoir 220. Said another way, the verification 230 can be configuredsuch that when the verification device 230 is disposed about any samplereservoir having a shape that substantially corresponds to the shape ofthe sample reservoir 220, the verification device 230 is disposed insubstantially the same relative position along that sample reservoir.

As shown in FIGS. 2 and 4, the verification device 230 includes a firstset of tabs 234A and a second set of tabs 235A that extend from aproximal end portion 231 of the verification device 230. The first setof tabs 234A includes, for example, a pair of tabs 234 that are arrangedopposite each other. Similarly, the second set of tabs 235A includes,for example, a pair of tabs 235 (different from the pair of tabs 234 ofthe first set of tabs 234A) that are arranged opposite each other. Inthis embodiment, the first set of tabs 234A and the second set of tabs235A extend from the proximal end portion 231 in an alternatingconfiguration. In other embodiments, the first set of tabs 234A and thesecond set of tabs 235A can be arranged in any suitable manner. Thefirst set of tabs 234A and the second set of tabs 235A collectivelydefine at least a portion of the inner volume 233 such that when theverification device 230 is disposed about the sample reservoir 220, thefirst set of tabs 234A and the second set of tabs 235A are disposedadjacent to an outer surface of the sample reservoir 220.

As shown in FIGS. 2 and 4, the first set of tabs 234A extend from theproximal end portion 231 a first distance and the second set of tabs235A extend from the proximal end portion 231 a second distance, greaterthan the first distance. Accordingly, when the verification device 230is disposed about a portion of the sample reservoir 220, an end portionof each tab 234 in the first set of tabs 234A (i.e., opposite theproximal end portion 231) is disposed at a first position along a lengthof the sample reservoir 220. Similarly, an end portion of each tab 235in the second set of tabs 235A (i.e., opposite the proximal end portion231) is disposed at a second position along a length of the samplereservoir 220, different from the first position.

In some embodiments, the first position and the second position can beassociated with, for example, a desired fill volume of the samplereservoir 220. For example, while a sample reservoir may havesubstantially the same shape and size as another sample reservoir, suchsample reservoirs can include different culture mediums and/or the like,each of which can be associated with, for example, a different fillheight for substantially the same fill volume. Thus, with theverification device 230 disposed in a substantially predeterminedposition about the sample reservoir 220 (as described above), the firstset of tabs 234 and the second set of tabs 235 can be associated with adesired fill height associated with a desired fill volume. Morespecifically, in this embodiment, the first set of tabs 234A can beassociated with a fill height corresponding to a fill volume of about 8mL to about 10 mL when the sample reservoir 220 includes an anaerobicculture medium. Similarly, the second set of tabs 235A can be associatedwith a fill height corresponding to a fill volume of about 8 mL to about10 mL when the sample reservoir 220 includes an aerobic culture medium.In other embodiments, a desired fill height can be associated with anysuitable fill volume such as, for example, a “micro” sample of just afew drops of blood (less than 1 ml), about 1 mL, about 2 mL, about 3 mL,about 4 mL, about 5 mL, about 6 mL, about 7 mL, or more.

As shown in FIG. 4, each tab 234 in the first set of tabs 234A and eachtab 235 in the second set of tabs 235A includes an indicator 236disposed at or near the end portion of the tabs 234 and/or 235. Theindicators 236 can be any suitable shape, size, or configuration and canselectively engage the sample reservoir 220. For example, when anindicator 236 of a tab 234 or 235 is placed in contact with the outersurface of the sample reservoir 220, the indicator 236 can mark, score,scribe, scrape, indent, and/or otherwise change a corresponding portionof the outer surface. In other words, the indicators 236 can each be amarker, a protrusion, a pointed surface, a cutting or scraping surface,and/or the like. Thus, the indicator 236 of a tab 234 or 235 can engagethe outer surface of the sample reservoir 220 to provide, for example, avisual indication on the outer surface of the sample reservoir 220associated with the position of that indicator 236.

In use, a user can position the verification device 230 about the samplereservoir 220 that includes, for example, an anaerobic culture medium.Once in a desired position, the user can exert a force on at least onetab 235 of the second set of tabs 235 such that the indicator 236disposed on the inner surface of that tab(s) 235 engages the outersurface of the sample reservoir 220. In this manner, the user can rotatethe verification device 230 about the sample reservoir 220, which inturn, results in the indicator(s) 236 of the second set of tabs 235providing a visual indication on the sample reservoir 220 associatedwith a desired fill volume of about 8 mL to about 10 mL corresponding tothe anaerobic culture medium disposed in the sample reservoir 220. Insome embodiments, the visual indication (e.g., the mark, line, etc.) canbe associated with and/or can be disposed along the volume indicatorportion 227 of the label 225. Thus, the volume indicator portion 227 canprovide an indication of, for example, an absolute volume within thesample reservoir 220 and/or a volume of bodily fluid within the samplereservoir relative to the culture medium disposed therein. Afterproviding, forming, and/or otherwise making the visual indication on theouter surface of the sample reservoir 220, the user can then transfer abodily fluid into the sample reservoir (e.g., via any suitable transferdevice described herein) and can stop the transfer of bodily fluid whena volume of the bodily fluid is substantially equal to the predeterminedvolume associated with the visual indication on the sample reservoir.

Similarly, a user can position the verification device 230 about thesample reservoir 220 that includes, for example, an aerobic culturemedium and can exert a force on at least one tab 234 of the second setof tabs 234A. Thus, when the user rotates the verification device 230about the sample reservoir 220, the indicator 236 disposed on the tab(s)234 provide a visual indication on the sample reservoir 220 associatedwith a desired fill volume of about 8 mL to about 10 mL corresponding tothe aerobic culture medium disposed in the sample reservoir 220. Theuser can then transfer a bodily fluid into the sample reservoir (e.g.,via any suitable transfer device described herein) and can stop thetransfer of bodily fluid when a volume of the bodily fluid issubstantially equal to the predetermined volume associated with thevisual indication on the sample reservoir.

Although not shown in FIGS. 2-4, in some embodiments, the first set oftabs 234A and the second set of tabs 235A can include, for example,indicia, a symbol, a color-coding, and/or the like associated with thetype of sample reservoir 220 with which that set of tabs corresponds.For example, in some embodiments, the sample reservoir 220 can include acolor-coding or the like that can provide an indication of the contentsof that sample reservoir 220 (e.g., aerobic or anaerobic). Thus, whenthe user positions the verification device 230 about the samplereservoir 220, the user can engage the set of tabs 234 or 235 having asimilar color-coding. In other embodiments, the sample reservoir 220 andthe set of tabs 234 and 235 can provide any suitable visual indicationconfigured to indicate a relationship between the first set of tabs 234and the sample reservoir 220 or the second set of tabs 235 and thesample reservoir 220. In some embodiments, the label 225 can besimilarly color-coded, which can allow a user to match the color-codingand/or to otherwise engage the tabs 234 or 235 having the matchingcolor.

While the volumetric verification device 230 is particularly shown anddescribed above with reference to FIGS. 2 and 4, in other embodiments,any suitable volumetric verification device can be disposed about asample reservoir to provide, for example, a visual indicator associatedwith a desired fill volume of the sample reservoir. For example, FIG. 5illustrates a verification device 330 disposed about a sample reservoir320, according to an embodiment. The sample reservoir 320 can be anysuitable reservoir configured to receive a bodily fluid such as, forexample, those described herein. For example, the sample reservoir 320includes at least a proximal end portion 321, a distal end portion 322,and a label 325 including a volume indicator portion 327. In thisembodiment, the sample reservoir 320 can be substantially similar to orthe same as the sample reservoir 220 described in detail above withreference to FIGS. 2-4. Thus, the sample reservoir 320 is not describedin further detail herein.

The volumetric verification device 330 (also referred to herein as“verification device 330”) includes a proximal end portion 331 and adistal end portion 332, and defines an inner volume 333. Theverification device 330 can be any suitable device, member, mechanism,assembly, etc. configured to provide a user with an indicator associatedwith a volume of the bodily fluid disposed within the sample reservoir320. In some embodiments, the verification device 330 can have a sizeand/or shape that substantially corresponds to the sample reservoir 320.For example, the verification device 330 can include an annular wallextending from a base and defining an inner volume (not shown in FIG.5). Said another way, the verification device 330 can be a sleeve or thelike configured to be disposed about a portion of the sample reservoir320. More specifically, the verification device 330 can be disposedabout the sample reservoir 320 such that the distal end portion 332 ofthe verification device 330 (e.g., a base or the like) is in contactwith the distal end portion 323 of the sample reservoir 320 and as such,is substantially in a predetermined position relative to the samplereservoir 320. Said another way, the verification device 330 can beconfigured such that when the verification device 330 is disposed aboutany sample reservoir having a shape that substantially corresponds tothe shape of the sample reservoir 320, the verification device 330 isdisposed in substantially the same relative position along that samplereservoir. Simply stated, the verification device 330 can be positionedabout the sample reservoir 320 such that a distal surface of the samplereservoir 320 (not shown in FIG. 5) is in contact with a distal, innersurface of the verification device 330.

The verification device 330 defines a first opening 337, a secondopening 338, and a viewing window 339. The viewing window 339 can be anysuitable shape and/or size and can allow a user to visualize a portionof the sample reservoir 320 when the verification device 330 is disposedabout the sample reservoir 320. In other embodiments, the verificationdevice 330 need not define the viewing window 339. Although not shown inFIG. 5, the verification device 330 can also define an identificationwindow or the like configured to substantially align with anidentification portion of the sample reservoir 320 such as, for example,a serial number, bar code, QR code, and/or the like (described abovewith reference to the sample reservoir 220). Thus, the identificationwindow can allow visualization of the identification portion when thesample reservoir 320 is disposed in the verification device 330.

The first opening 337 and the second opening 338 can be any suitableshape, size, and/or arrangement. As shown in FIG. 5, the first opening337 and the second opening 338 can be, for example, slots that extendalong a portion of the circumference of the verification device 330.While the first opening 337 is shown as being smaller than the secondopening 338, in other embodiments, the first opening 337 and the secondopening 338 can have substantially the same shape and/or size or thefirst opening 337 can be larger than the second opening 338. In thismanner, the first opening 337 and the second opening 338 can allow auser to visualize a portion of the sample reservoir 320 when the samplereservoir 320 is disposed therein.

When the verification device 330 is disposed about a desired portion ofthe sample reservoir 320 (as described above), the first opening 337 isdisposed at a first position along a length of the sample reservoir 320,the second opining 338 is disposed at a second position along a lengthof the sample reservoir 320, different from the first position. In someembodiments, the first position and the second position can beassociated with, for example, a position of a culture medium within thesample reservoir 320 and a desired fill volume of the sample reservoir320, respectively. For example, while a sample reservoir may havesubstantially the same shape and size as another sample reservoir, suchsample reservoirs can include different culture mediums and/or the like,each of which can be associated with, for example, a different fillheight for substantially the same fill volume. Said another way, thefirst opening 337 and the second opening 338 are spaced apart by apredetermined and/or desired distance such that when the verificationdevice 330 is disposed about a desired portion of the sample reservoir320, a portion of the inner volume of the sample reservoir 320 isdefined therebetween. In some embodiments, this portion of the innervolume of the sample reservoir 320 is substantially equal to a volume ofthe culture medium. In other words, the culture medium has substantiallythe same volume as the portion of the inner volume of the samplereservoir 320 defined between the first opening 337 and the secondopening 338. In this manner, the predetermined and/or desired fillheight and/or volume is equal to and/or based on a sum of a volume ofbodily fluid transferred into the inner volume and a volume of theculture medium.

In some embodiments, with the verification device 330 disposed in asubstantially predetermined position about the sample reservoir 320 (asdescribed above) the first opening 337 can, for example, correspond witha height of a culture medium disposed in the sample reservoir 320 andthe second opening 338 can be associated with a desired fill volumecorresponding to that culture medium. More specifically, the firstopening 337 can allow for visualization of a culture medium and thesecond opening 338 can be associated with and/or can allow forvisualization of a fill height and/or a fill volume of about 8 mL toabout 10 mL respective to the culture medium disposed therein. In thismanner, the verification device 330 can be configured to correspond to agiven sample reservoir based at least in part on the relative positionof the first opening 337 and the second opening 338. For example, afirst verification device can define a first opening and a secondopening at a first position associated with a fill volume of about 8 mLto about 10 mL relative to an anaerobic culture medium, while a secondverification device can define a first opening and a second opening at asecond position associated with a fill volume of about 8 mL to about 10mL relative to an aerobic culture medium. In other embodiments, averification device can include any number of openings associated withvarious points of interest within the sample reservoir.

In use, a user can position the verification device 330 about the samplereservoir 320 that includes, for example, an anaerobic or an aerobicculture medium. Once in a desired position, the user can visualize theculture medium via the first opening 337 and a portion of the innervolume of the sample reservoir 320 associated with a desired fill volumeof about 8 mL to about 10 mL corresponding to the anaerobic or aerobicculture medium disposed therein. In some embodiments, the first opening337 and the second opening 338 can allow for visualization of a portionof the volume indicator portion 327 of the label 325. Thus, the volumeindicator portion 327 can provide an indication of, for example, anabsolute volume within the sample reservoir 320 and/or a volume ofbodily fluid within the sample reservoir 320 relative to the culturemedium disposed therein. With the verification device 330 in the desiredposition, the user can then transfer a bodily fluid into the samplereservoir 320 (e.g., via any suitable transfer device described herein)and can stop the transfer of bodily fluid when a volume of the bodilyfluid is visible via the second opening 338. Thus, a predeterminedvolume of bodily fluid can be transferred to the sample reservoir 320.

Although not shown in FIG. 5, in some embodiments, the verificationdevice 330 can include, for example, indicia, a symbol, a color-coding,and/or the like associated with the type of sample reservoir 320 withwhich the verification device 330 (e.g., the openings 337 and 338)corresponds. For example, in some embodiments, the sample reservoir 320can include a color-coding or the like that can provide an indication ofthe contents of that sample reservoir 320 (e.g., aerobic or anaerobic)and the corresponding verification device 330 can include a similarcolor-coding or the like. In other embodiments, the sample reservoir 320and/or the verification device 330 can provide any suitable visualindication configured to indicate a relationship therebetween.

While not shown in FIG. 5, in some embodiments, the verification device330 can include any suitable adjustment mechanism or the like configuredto adjust the position of the verification device 330 relative to thesample reservoir 320. For example, as described above, the verificationdevice 330 can be disposed about the sample reservoir 320 such that thedistal surface of the sample reservoir 320 is in contact with thedistal, inner surface of the verification device 330. In someembodiments, however, the distal, inner surface can be an adjustablesurface configured to move in a proximal or distal direction in responseto a user input. For example, in some embodiments, the surface can becoupled to a screw or threaded coupling or platform. In suchembodiments, the user can manipulate an engagement portion or the like(not shown) to rotate the screw or threaded coupling, which in turn, canmove the distal, inner surface in the proximal or the distal direction.Thus, with the distal surface of the sample reservoir 320 in contactwith the adjustable inner surface of the verification device 330, theuser can adjust the position of the sample reservoir 320 relative to,for example, the first opening 337 and the second opening 338.

In some embodiments, this adjustment can account for manufacturingtolerances associated with the sample reservoir 320, verification device330, and/or additive contained in the sample reservoir 320. For example,in some embodiments, the additive can include a CO₂ detection element orsubstance that can have a variable height or volume while the remainingportions of the additive otherwise have a predetermined size and/orvolume (e.g., within a given tolerance). Thus, the user can manipulatethe engagement portion and/or any suitable portion of an adjustmentmechanism to account for such variances. Moreover, by having a fixeddistance between the first opening 337 and the second opening 338 and byaligning the first opening with a top surface or meniscus of theadditive, filling the sample reservoir 320 with a volume of bodily fluiduntil the top surface or meniscus of the bodily fluid is aligned withthe second opening 338 will result in a predetermined ratio between thebodily fluid volume and the volume of the additive regardless of thevariances described above. Although described above as being a screw orthreaded coupling, an adjustment mechanism or the like can be anysuitable device or combination of devices (e.g., a slider, wedge,spring, handle, etc.).

While the volumetric verification device 330 is particularly shown anddescribed above with reference to FIG. 5, in other embodiments, anysuitable volumetric verification device can be disposed about a samplereservoir to provide, for example, a visual indicator associated with adesired fill volume of the sample reservoir. For example, FIG. 6illustrates a volumetric verification device 430 disposed about a samplereservoir 420, according to an embodiment. The sample reservoir 420 canbe any suitable reservoir configured to receive a bodily fluid such as,for example, those described herein. For example, the sample reservoir420 includes at least a proximal end portion 421, a distal end portion422, and a label 425 including a volume indicator portion 427. In thisembodiment, the sample reservoir 420 can be substantially similar to orthe same as the sample reservoir 220 described in detail above withreference to FIGS. 2-4. Thus, the sample reservoir 420 is not describedin further detail herein.

The volumetric verification device 430 (also referred to herein as“verification device 430”) includes a proximal end portion 431 and adistal end portion 432, and defines an inner volume 433. Theverification device 430 can be any suitable device, member, mechanism,assembly, etc. configured to provide a user with an indicator associatedwith a volume of the bodily fluid disposed within the sample reservoir420. For example, the verification device 430 can be substantiallysimilar to the verification device 330 described above with reference toFIG. 5; thus, some aspects of the verification device 430 are notdescribed in further detail herein. For example, as shown in FIG. 6, theverification device 430 defines a first opening 437 and a second opening438. In some embodiments, the first opening 437 and the second opening438 can be substantially similar in form and function to the firstopening 337 and the second opening 338 of the verification device 330.

The verification device 430 can differ from the verification device 330,however, by being and/or having a shorter length and a substantiallyopen distal end portion 432. That is to say, the verification device 430is, for example, a sleeve disposed about a portion of the samplereservoir 420. In some embodiments, such an arrangement can allow theverification device 430 to be moved along a length of the fluidreservoir 420. Specifically, in use, a user can position theverification device 430 about the sample reservoir 420 such that a topsurface of a culture medium disposed in the sample reservoir 420 is atleast partially aligned with and viewable through the first opening 437.As such, the second opening 438 can be associated with a desired fillvolume of the sample reservoir 420 relative to the culture mediumdisposed therein. Similarly stated, the position of the second opening438 is based, at least in part, on the position of the first opening437. In some instances, the position of the second opening 438 can beassociated with and/or can allow for visualization of a fill heightand/or a fill volume of about 8 mL to about 10 mL respective to theculture medium disposed therein. In addition, the second opening 438 canallow for visualization of the indicator portion 427 of the samplereservoir 420. Thus, the volume indicator portion 427 can provide anindication of, for example, an absolute volume within the samplereservoir 420 and/or a volume of bodily fluid within the samplereservoir 420 relative to the culture medium disposed therein. With theverification device 430 in the desired position, the user can thentransfer a bodily fluid into the sample reservoir 420 (e.g., via anysuitable transfer device described herein) and can stop the transfer ofbodily fluid when a volume of the bodily fluid is visible via the secondopening 438. Thus, a predetermined volume of bodily fluid can betransferred to the sample reservoir 420.

In some embodiments, a sample reservoir can be configured to engageand/or couple to a volumetric verification device (such as thosedescribed herein), which in turn is coupled to a cradle, mountingdevice, holder, and/or the like configured to facilitate the procurementof a sample. For example, FIGS. 7-10 illustrate a pair of volumetricverification devices 530 and 530′ that can be coupled to a cradle 550and that are configured to receive a portion of a sample reservoir 520and 520′, respectively. The sample reservoirs 520 and 520′ can be anysuitable sample reservoir such as any of those described herein. Forexample, as shown in FIG. 7, the sample reservoir 520 includes at leasta proximal end portion 521, a distal end portion 522, and a label 525having at least a volume indicator portion 527. Similarly, the samplereservoir 520′ includes at least a proximal end portion 521′, a distalend portion 522′, and a label 525 having at least a volume indicatorportion 527′. Moreover, the sample reservoir 520 can be substantiallythe same as the sample reservoir 520′ (e.g., the sample reservoirs 520and 520′ can each include an aerobic culture medium or can each includean anaerobic culture medium). In this embodiment, however, the samplereservoir 520 includes, for example, an anaerobic culture medium, whilethe sample reservoir 520′ includes, for example, an aerobic culturemedium (or vice versa). In this manner, the sample reservoirs 520 and520′ can be substantially similar in form and function as the samplereservoir 220 described above with reference to FIGS. 2-4; thus, thesample reservoirs 520 and 520′ are not described in further detailherein.

The verification devices 530 and 530′ can be any suitable volumetricverification device such as those described herein. By way of example,the verification device 530 includes a proximal end portion 531 and adistal end portion 532, and defines an inner volume 533 configured toreceive a portion of the sample reservoir 520. Furthermore, theverification device 530 defines a first opening 537, a second opening538, a viewing window 539, and an identification window 540. Similarly,the verification device 530′ includes a proximal end portion 531′ and adistal end portion 532′, and defines an inner volume 533′ configured toreceive a portion of the sample reservoir 520′. Furthermore, theverification device 530′ defines a first opening 537′, a second opening538′, a viewing window 539′, and an identification window 540′. In someembodiments, the verification devices 530 and 530′ can be substantiallythe same. For example, the verification devices 530 and 530′ can each beconfigured to receive a sample reservoir of the same type (e.g.,including an aerobic culture medium or an anaerobic culture medium). Inthis embodiment, however, the verification device 530 receives thesample reservoir 520 including, for example, the anaerobic culturemedium (as described above), while the verification device 530′ receivesthe sample reservoir 520′ including, for example, the aerobic culturemedium (or vice versa).

As shown in FIG. 7, the arrangement of the verification device 530 issuch that when the sample reservoir 520 is disposed in the verificationdevice 530, the first opening 537 is substantially aligned with a topsurface of the culture medium disposed in the sample reservoir 520. Inaddition, the second opening 538 is spaced a distance from the firstopening 537 to allow for visualization of a meniscus of a volume ofbodily fluid when the volume is within a desired range or tolerance ofvolumes associated with that culture medium (e.g., about 8 mL to about10 mL), as described in detail above with reference to the verificationdevice 330 and sample reservoir 320 in FIG. 5. The first opening 537′and the second opening 538′ of the verification device 530′ aresimilarly arranged relative to the sample reservoir 520′. In thismanner, the verification devices 530 and 530′ can be substantiallysimilar in form and function as the verification device 330 described inreference to FIG. 5; thus, aspects of the verification devices 530 and530′ that are similar to the corresponding aspects of the verificationdevice 330 in FIG. 5 are not described in further detail herein.

The verification devices 530 and 530′ can differ from the verificationdevice 330, however, by being configured to couple to the cradle 550.For example, as shown in FIGS. 8 and 9, the verification devices 530 and530′ are coupled to and/or otherwise include a coupling portion 545having a set of coupling members 546. In some embodiments, the couplingportion 545 can be unitarily formed with the verification devices 530and 530′. In other embodiments, the coupling portion 545 can be attachedand/or otherwise coupled to the verification devices 530 and 530′ via,for example, ultrasonic welding, an adhesive, an interference fit, asnap fit, a mechanical fastener (e.g., bolt, screw, rivet, etc.), and/orthe like. The coupling members 546 can extend from a surface of thecoupling portion (e.g., a surface opposite the surface in contact withthe verification devices 530 and 530′) to selectively engage acorresponding set of coupling members 553 on the cradle 550, asdescribed in further detail herein. Although shown in FIG. 9 asincluding two coupling members 546, in other embodiments, the couplingportion 545 can include any suitable number of coupling members 546 suchas, for example, one, three, four, five, or more.

The cradle 550 includes a body portion 551 and a coupling portion 552.The body portion 551 can be any suitable shape, size, or configuration.For example, as shown in FIG. 10, the body portion 551 can have across-sectional shape that is substantially U-shaped. In someembodiments, the shape and/or size of the body portion 551 can beassociated with a portion of the human body and/or a portion of an itemabout which the body portion 551 can be disposed. For example, in thisembodiment, the body portion 551 has a shape and size associated with aportion of a human arm. In other words, the body portion 551 isconfigured to be disposed about a portion of a user's arm or a portionof a patient's arm. Said another way, a portion of a user's arm can bedisposed within the substantially U-shaped body portion 551, thereby atleast temporarily coupling the cradle 550 to the user's arm. In otherembodiments, the body portion 551 can have a size and/or shapeassociated with, for example, a hospital bed rail, and or any othersuitable structure (e.g., an inanimate structure). In some embodiments,the body portion 551 can be formed from a relatively resilient materialand/or the like that can allow the body portion 551 to be bent, flexed,deformed, molded, and/or otherwise substantially conformed about aportion of the human body (e.g., an arm) or a portion of any othersuitable object. Thus, the cradle 550 can be maintained in a relativelyfixed position relative to the item or portion of the body about whichthe body portion 551 is disposed.

The coupling portion 552 of the cradle 550 includes the set of couplingmembers 553. As described above, the coupling members 553 are configuredto engage and/or couple to the corresponding coupling members 546 of thecoupling portion 545 to couple the verification devices 530 and 530′ tothe cradle 550. For example, as shown in FIG. 10, the coupling members553 extend from a surface of the coupling portion 552 and each include atriangular and/or wedge-shaped flange. Accordingly, the coupling members546 of the coupling portion 545 can have a size and shape associatedwith the coupling members 553 of the cradle 550. Thus, the couplingportion 545 can be manipulated to dispose the coupling members 546 ofthe coupling portion 545 about the coupling members 553 of cradle 550 todefine, for example, a friction fit, an interference fit, a snap fit,and/or the like, which in turn, is operative in coupling theverification devices 530 and 530′ to the cradle 550. In otherembodiments, the coupling portion 545 attached and/or coupled to theverification devices 530 and 530′ can be coupled to the coupling portion552 of the cradle 550 in any suitable manner. Thus, in use, the samplereservoirs 520 and 520′ can be disposed in the verification devices 530and 530′, which in turn, are coupled to the cradle 550. Thus, the cradle550 can be positioned relative to and/or disposed about a portion of thehuman body and/or any other suitable object to limit movement of thesample reservoirs 520 and 520′ when being filled with a bodily fluidand/or when a user is visualizing the contents of the sample reservoirs520 and/or 520′ via the first opening 537 and/or the second opening 538of the verification device 530 and/or the first opening 537′ and/or thesecond opening 538′ of the verification device 530′, respectively.

FIG. 11 is a flowchart illustrating a method 10 of verifying a samplevolume according to an embodiment. The method includes coupling avolumetric verification device to a sample reservoir containing anadditive such that an indicator is in a predetermined position along alength of the sample reservoir, at 11. For example, as described abovewith reference to the verification device 230, a user can position theverification device about the sample reservoir to place the indicator ina desired position. The desired position can be, for example, associatedwith a desired fill volume and/or fill height of the sample reservoir.In some embodiments, the indicator can be a marker or the likeconfigured to produce a mark on a portion of the sample reservoir suchas a label (as described above with reference to the sample reservoir220). In such embodiments, the user can exert a force on a portion ofthe verification device to place the indicator in contact with a portionof the sample reservoir and can rotate the verification device about thesample reservoir, which in turn, results in the indicator providing avisual indication on the sample reservoir associated with a desired fillvolume. While the indicator is described as being a marker, in otherembodiments, the indicator can be, for example, a window or the likedefined by the verification device, as described above with reference tothe verification device 330.

With the indicator in the predetermined position, fluid communication isestablished between a patient and the sample reservoir, at 12. Forexample, the sample reservoir can be placed in fluid communication withany suitable fluid transfer device such as those described herein. Avolume of bodily fluid is transferred from the patient to the samplereservoir, at 13. In some embodiments, the volume of bodily fluid can bebased on the additive (e.g., culture medium or the like) disposed in thesample reservoir. In some embodiments, the volume of bodily fluid can bebetween about 8 mL and about 10 mL. In other words, the desired fillvolume of the sample reservoir can be between about 8 mL and about 10 mLcorresponding to the additive disposed in the sample reservoir. Forexample, as described above, the additive can be a culture medium suchas an aerobic culture medium, an anaerobic culture medium, and/or thelike, each of which is associated with a predetermined fill volume ofthe sample reservoir.

The method 10, includes verifying the volume of bodily fluid transferredto the sample reservoir is substantially the predetermined volume ofbodily fluid, at 14. For example, the user can transfer a bodily fluidinto the sample reservoir (e.g., via any suitable transfer devicedescribed herein) and can stop the transfer of bodily fluid when avolume of the bodily fluid is substantially equal to the predeterminedvolume associated with the position of the indicator. More specifically,the user can stop the transfer of bodily fluid when a surface and/ormeniscus of the bodily fluid within the sample reservoir issubstantially aligned with the indicator. In this manner, a verificationdevice corresponding to a given culture medium and/or additive can beused to verify a sample volume of bodily fluid is within, for example,an accepted tolerance and/or the like.

Although not shown in FIGS. 2-10, the sample reservoirs 220, 320, 420,520, and 520′ and the verification devices 230, 330, 430, 530, and 530′can be used with any suitable fluid transfer device such as, forexample, those described above with reference to FIG. 1. For example,such a transfer device can be any substantially similar to and/or thesame as any of those described in the '724 patent and/or the '782Publication, incorporated by reference above. Thus, in use, such atransfer device can be placed in fluid communication with the samplereservoirs 220, 320, 420, 520 and/or 520′ and the transfer device can beplaced in a configuration in which a first volume of bodily fluid and/ora pre-sample volume of bodily fluid is diverted into, for example, apre-sample reservoir. In this manner, undesirable microbes such as, forexample, dermally residing microbes dislodged during a venipuncture canbe transferred into to the pre-sample reservoir.

Once predetermined volume of bodily fluid is disposed in the pre-samplereservoir, the pre-sample reservoir is fluidically isolated from theport to sequester the pre-sample volume of bodily fluid in thepre-sample reservoir. In some embodiments, the predetermined pre-samplevolume can be about 0.1 mL, about 0.3 mL, about 0.5 mL, about 1.0 mL,about 2.0 mL, about 4.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL,about 20 mL, about 50 mL, and/or any volume or fraction of a volumetherebetween. In other embodiments, the pre-sample volume can be greaterthan 50 mL or less than 0.1 mL. In other embodiments, the predeterminedpre-sample volume can be between about 2 mL and about 5 mL. In stillother embodiments, the predetermined pre-sample volume can be about 4mL. Thus, once the pre-sample reservoir is fluidically isolated, thetransfer device can be manipulated to transfer, for example, a samplevolume of bodily fluid into any of the sample reservoirs 220, 320, 420,520, and/or 520′. Moreover, as the bodily fluid is transferred to thesample reservoir 220, 320, 420, 520, and/or 520′, any of theverification devices 230, 330, 430, 530, and/or 530′ can be used toverification and/or otherwise determine a sample volume within thesample reservoir 220, 320, 420, 520, and/or 520′. In some embodiments,the sample volume of bodily fluid can be any suitable volume of bodilyfluid from, for example, one or a few drops of bodily fluid (e.g.,nanoliters or microliters) to 10 mL, 20 ml, 30 mL, 40 mL, 50 mL, 100 mL,1,000 mL, 10,000 mL, or more (or any value or fraction of a valuetherebetween) of bodily fluid. As such, the embodiments described hereincan significantly reduce the occurrence of false-positives orfalse-negatives from post-collection analysis.

The embodiments described herein can be formed from any suitablematerial or combination of materials. For example, the embodimentsdescribed herein can be formed from a biocompatible plastic or the like,and such embodiments can be, for example, reusable. Alternatively, anyof the embodiments described herein can be formed from a cardboardand/or paper product, and such embodiments can be, for example,disposable.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Although variousembodiments have been described as having particular features and/orcombinations of components, other embodiments are possible having acombination of any features and/or components from any of embodiments asdiscussed above.

Any of the embodiments and/or components of the embodiments can bepackaged and sold independently or packaged and sold as a kit having anysuitable combination of components. For example, in some embodiments, akit can include any one of the sample reservoirs described herein andany one of the verification devices described herein. In someembodiments, a kit can include multiple sample reservoirs (e.g., two ormore) and multiple verification devices (e.g., two or more). In somesuch embodiments, the sample reservoirs can be substantially the sameand can contain, for example, substantially the same additive and/orculture medium. Accordingly, the verification devices can each besubstantially the same and can correspond to and/or can be associatedwith the additive disposed in the sample reservoirs. In otherembodiments, the sample reservoirs can have substantially the same sizeand/or shape but can contain different culture mediums, reagents,additives, amounts of negative pressure, and/or the like. As such, thekit can include at least one verification device configured for use witheach sample reservoirs. In some such embodiments, the verificationdevices can each be the same and can be configured for use with, forexample, aerobic or anaerobic culture mediums such as, for example, theverification device 220 described above. In other embodiments, theverification devices can be different and configured for use with oneculture medium such as the verification device 330. While kits aredescribed as including at least one sample reservoir and at least oneverification device, in other embodiments, a kit can include multipleverification devices (two or more) without one or more sample devices(or vice versa). In such embodiments, a kit can be a multi-pack of thesame verification devices or a multi-pack of the same sample reservoirs.In other embodiments, a kit can be a variety of verification devices ora variety of sample devices. In still other embodiments, a kit caninclude a cradle or the like such as the cradle 550 and/or can includeany other coupling and/or retention device. In some embodiments, a kitcan include one or more verification devices, one or more samplereservoirs, and any suitable fluid transfer or portion thereof.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired volume of bodily fluid or a desired rate of bodily fluid flowinto a sample reservoir. For example, while the sample reservoirs areparticularly shown and described herein, the verification devicesdescribed herein can be used with any suitable fluid reservoir. Forexample, in some embodiments, a sample reservoir can be substantiallysimilar to or the same as known sample containers such as, for example,a Vacutainer® (manufactured by BD), a BacT/ALERT® SN or BacT/ALERT® FA(manufactured by Biomerieux, Inc.), a Nanotainer™ (manufactured byTheranos), and/or any suitable reservoir, vial, microvial, microlitervial, container, microcontainer, and/or the like. As such the sizeand/or configuration of the sample reservoir can be based on, forexample, a volume of bodily fluid configured to be contained therein.

In some embodiments, a collection device can include a flow-meteringdevice and/or any other mechanism, device, or method configured tomeasure volumetric flow rates and/or characteristics of a bodily fluidsuch as, for example, a pressure sensor, a voltage sensor, a photosensor, a velocity sensor, a flow meter, a strain gauge, a valve, aturbine, a float, displacement analysis, density analysis, weightanalysis, optical analysis, ultrasound analysis, thermal analysis,Doppler analysis, electromagnetic field (emf) analysis, reflectionanalysis, obstruction analysis, area analysis, venturi analysis,coriolis analysis, visual analysis, and/or any other suitable sensor,analysis, and/or calculation (e.g., applying and/or using, for example,Boyle's law, ideal gas law, force calculation (force=mass*acceleration),and/or the like). For example, any of the embodiments described hereincan include a flow-metering device such as those described in the '782Publication.

Where methods and/or events described above indicate certain eventsand/or procedures occurring in certain order, the ordering of certainevents and/or procedures may be modified. Additionally, certain eventsand/or procedures may be performed concurrently in a parallel processwhen possible, as well as performed sequentially as described above.

1.-28. (canceled)
 29. A method for verifying a sample volume of bodilyfluid withdrawn from a patient using a volumetric verification device,the method comprising: coupling the volumetric verification device to asample reservoir to place an indicator associated with the volumetricverification device in a position along a length of the sample reservoirassociated with a predetermined volume of bodily fluid configured to betransferred into an inner volume of the sample reservoir, the innervolume containing an additive; establishing fluid communication betweenthe patient and the sample reservoir; transferring a volume of bodilyfluid from the patient to the sample reservoir; and verifying the volumeof bodily fluid transferred to the sample reservoir is substantially thepredetermined volume via the indicator.
 30. The method of claim 29,wherein the indicator is a marker, the method further comprising:manipulating the volumetric verification device such that the markerforms a mark on a volumetric indicator portion of the sample reservoir.31. The method of claim 30, wherein the transferring of the volume ofbodily fluid from the patient to the sample reservoir includestransferring bodily fluid to the sample reservoir until a meniscus ofthe bodily fluid within the sample reservoir is substantially alignedwith the mark.
 32. The method of claim 30, wherein the verifying of thevolume of bodily fluid transferred to the sample reservoir includesvisually verifying a surface of the bodily fluid within the samplereservoir is substantially aligned with the mark.
 33. The method ofclaim 29, wherein the indicator is a window defined by the volumetricverification device, the verifying of the volume of bodily fluidtransferred to the sample reservoir includes visually verifying asurface of the bodily fluid within the sample reservoir is substantiallyaligned with the window.
 34. The method of claim 29, wherein theindicator is a first indicator, the volumetric verification deviceincludes a second indicator, the coupling of the volumetric verificationdevice to the sample reservoir includes coupling the volumetricverification device to the sample reservoir such that the firstindicator is substantially aligned with the predetermined volume whenbodily fluid is transferred into the inner volume and the secondindicator is substantially aligned with a surface of the additive. 35.The method of claim 29, wherein a portion of the sample reservoir has acolor based on the additive contained in the sample reservoir, themethod further comprising: selecting, prior to the coupling of thevolumetric verification device to the sample reservoir, the volumetricverification device from a plurality of volumetric verification devicesbased at least in part on a color of a portion of the volumetricverification device matching the color of the portion of the samplereservoir.
 36. The method of claim 29, wherein the additive is one of anaerobic culture medium or an anaerobic culture medium.
 37. A method forverifying a sample volume of bodily fluid transferred from a patient toa sample reservoir, the method comprising: coupling a volumetricverification device to the sample reservoir; manipulating the volumetricverification device to place an indicator associated with the volumetricverification device in a position along a volumetric indicator portionof the sample reservoir, the position along the volumetric indicatorportion being associated with a predetermined fill volume based at leastin part on an additive contained in an inner volume of the samplereservoir; establishing fluid communication between the patient and thesample reservoir; and transferring a flow of bodily fluid from thepatient to the sample reservoir until a surface of a volume of bodilyfluid contained in the sample reservoir is substantially aligned withthe indicator.
 38. The method of claim 37, wherein the indicator is amarker, the manipulating of the volumetric verification device includesplacing a mark on the volumetric indicator portion of the samplereservoir using the marker.
 39. The method of claim 37, wherein theindicator is a marker, the manipulating of the volumetric verificationdevice includes placing a mark on the volumetric indicator portion ofthe sample reservoir using the marker, the method further comprising:removing the volumetric verification device from the sample reservoirafter placing the mark on the volumetric indicator portion of the samplereservoir and prior to the transferring of the flow of bodily fluid fromthe patient to the sample reservoir.
 40. The method of claim 37, whereinthe predetermined fill volume is a sum of a volume of the additive and apredefined volume of the bodily fluid based on the additive.
 41. Themethod of claim 37, wherein the additive is one of an aerobic culturemedium or an anaerobic culture medium.
 42. The method of claim 37,wherein the indicator is a first indicator, the sample reservoirincluding a second indicator indicative of the additive contained in theinner volume of the sample reservoir, the method further comprising:providing the volumetric verification device based on the secondindicator.
 43. The method of claim 42, wherein the second indicator is acolor of at least a portion of the sample reservoir, a color of at leasta portion of the volumetric verification device matching the color of atleast the portion of the sample reservoir.
 44. The method of claim 37,wherein the volumetric verification device is from a plurality ofvolumetric verification devices and the sample reservoir is from aplurality of sample reservoirs, a color of at least a portion of eachvolumetric verification device from the plurality of volumetricverification devices being based on a color of at least a portion of asample reservoir from the plurality of sample reservoirs, the methodfurther comprising: selecting the volumetric verification device fromthe plurality of volumetric verification devices based at least in parton the color of at least the portion of the volumetric verificationdevice from the plurality of volumetric verification devices matchingthe color of at least the portion of the sample reservoir from theplurality of sample reservoirs.
 45. A method for verifying a samplevolume of bodily fluid transferred from a patient to a sample reservoir,the sample reservoir including a first indicator, the first indicatorbeing indicative of an additive contained in an inner volume of thesample reservoir, the method comprising: coupling a volumetricverification device based on the first indicator to the samplereservoir, the volumetric verification device including a secondindicator and a third indicator; manipulating the volumetricverification device to (1) substantially align the second indicator witha surface of the additive contained in the inner volume of the samplereservoir and (2) place the third indicator in a position along a lengthof the sample reservoir associated with a predetermined fill volumebased on the additive contained in the inner volume of the samplereservoir; and transferring a flow of bodily fluid from the patient tothe sample reservoir until a surface of a volume of bodily fluidcontained in the sample reservoir is substantially aligned with thethird indicator.
 46. The method of claim 45, wherein the additive is oneof an aerobic culture medium or an anaerobic culture medium.
 47. Themethod of claim 45, wherein the predetermined fill volume is a sum of avolume of the additive and a predefined volume of bodily fluid based onthe additive.
 48. The method of claim 45, wherein the predetermined fillvolume is a sum of a volume of the additive and a predefined volume ofbodily fluid based on the additive, the volume of bodily fluid containedin the sample reservoir is substantially equal to the predefined volumeof bodily fluid when the surface of the volume of bodily fluid containedin the sample reservoir is substantially aligned with the thirdindicator.
 49. The method of claim 45, wherein the first indicator is acolor of at least a portion of the sample reservoir, a color of at leasta portion of the volumetric verification device matching the color of atleast the portion of the sample reservoir.
 50. The method of claim 45,wherein the volumetric verification device is from a plurality ofvolumetric verification devices and the sample reservoir is from aplurality of sample reservoirs, a color of at least a portion of eachvolumetric verification device from the plurality of volumetricverification devices being based on a color of at least a portion of asample reservoir from the plurality of sample reservoirs, and the firstindicator is the color of at least the portion of the sample reservoirfrom the plurality of sample reservoirs, the color of at least theportion of the volumetric verification device from the plurality ofvolumetric verification devices matching the color of at least theportion of the sample reservoir from the plurality of sample reservoirs.51. The method of claim 45, wherein the second indicator is a firstwindow defined by the volumetric verification device and the thirdindicator is a second window defined by the volumetric verificationdevice.
 52. The method of claim 51, wherein the manipulating of thevolumetric verification device is such that the surface of the additiveis visible via the first window defined by the volumetric verificationdevice, the method further comprising: stopping the transfer of the flowof bodily fluid from the patient to the sample reservoir when thesurface of the volume of bodily fluid in the sample reservoir is visiblevia the second window defined by the volumetric verification device.